Director, Analytical Development (Small Molecule)
Structure Therapeutics is seeking a Director of Analytical Development to lead analytical activities supporting late-stage development, Phase 3 programs, process performance qualification (PPQ), commercialization, and global regulatory filings. This role involves overseeing method development, qualification, validation, specification strategy, stability programs, and analytical control systems across drug substances and drug products.
Key responsibilities include developing and implementing analytical strategies for small molecule APIs and drug products, ensuring alignment with ICH guidelines and regulatory standards. The Director will oversee method development, optimization, qualification, and validation, as well as impurity control strategy development. Additionally, the role involves partnering with Quality Control and Quality Assurance teams to manage release testing, stability testing, and GMP support activities, ensuring compliance and readiness for PPQ and commercial operations.
The ideal candidate will possess a B.S. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline, with 10+ years of relevant industry experience, or an advanced degree with commensurate experience. Deep expertise in analytical development for small molecule APIs and oral solid dose products is essential, along with significant experience in regulatory dossier authorship and defense. A strong understanding of GMP QC operations, data integrity, and the ability to operate effectively in a fast-paced, matrixed organization are also required.
Structure Therapeutics offers a competitive compensation package, including an anticipated base pay range of $205,000 to $258,000, annual performance incentive bonuses, new hire equity, and ongoing performance-based equity. Benefits include medical, dental, and vision insurance, 401(k) match, unlimited PTO, and paid holidays, including a winter shutdown.
Joining Structure Therapeutics means becoming part of a dynamic team dedicated to developing life-changing medicines using advanced structure-based and computational drug discovery technologies. The company fosters a collaborative and innovative culture, providing opportunities for professional growth and the chance to make a significant impact in addressing chronic diseases with high unmet needs.